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Cost-utility Analysis Treatment of Bartholin's Abscess : Word Catheter Versus Incision-drainage. (BARTHO-KT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04093310
Recruitment Status : Recruiting
First Posted : September 18, 2019
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:
Bartholin's gland abscess is a condition requiring emergency consultation. Placement of a Word catheter, which is a minor technique used in France as a treatment of bartholin's Abscess, can be done in an emergency room without hospitalization. Actually, incision-drainage, which is the most widespread treatment in France, is performed on day surgery with or without overnight hospitalization. Our hypothesis is that the use of Word catheter compared to incision-drainage would not modify the quality of life of the patients but would allow a saving of up to 3 M€ per year in France.

Condition or disease Intervention/treatment Phase
Bartholin's Gland Abscess Treatment Device: Word Catheter Procedure: Incision-drainage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cost-utility Analysis Treatment of Bartholin's Abscess : Word Catheter Versus Incision-drainage.
Actual Study Start Date : January 17, 2020
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

Arm Intervention/treatment
Experimental: Word catheter
The abscess is incised and the Word catheter is inserted into the residual cavity to create a neo-channel to prevent recurrence. The catheter is removed after 4 weeks during a consultation
Device: Word Catheter
Use of the Word catheter to remove the Bartholin's abscess

Active Comparator: Incision-drainage
This procedure performed under general or loco-regional anaesthesia consists in incising the abscess, draining the pus build-up and placing a wick in the residual cavity to promote progressive healing from the inside out.
Procedure: Incision-drainage
Incision-drainage to remove the Bartholin's abscess




Primary Outcome Measures :
  1. cost-utility ratio, according to the societal perspective of the of the management of Bartholin's gland abscess by the Word catheter compared to the incision-drainage [ Time Frame: 12 months ]

    The utility will be measured by:

    Quality Adjusted Life Year (QALYs) as estimated from responses to the Euroqol-5 Dimensions (EQ-5D 5L) health-related quality of life questionnaire. The questionnaire focuses on 5 dimensions: mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression. For each of these dimensions, 5 answers are possible.

    The costs will be measured by the addition of the following costs:

    Outpatient resource consumption collected in a declarative patient questionnaire. Hospital care resources using the the database of the Medicalised Information System Program of each recruiting site



Secondary Outcome Measures :
  1. Budget impact analysis for the health insurance point of view in case of diffusion of the Word catheter [ Time Frame: 5 years ]
    Comparison of intervention costs on the study sample and projection of these costs over 5 years, from the health insurance and hospital perspectives

  2. Non inferiority evaluation of Word catheter vs. Incision drainage in terms of pain [ Time Frame: at baseline and day 1 ]
    Pain numeric scale from 0 to 10

  3. Non inferiority evaluation of Word catheter versus incision-drainage in terms of recurrence rate [ Time Frame: 12 months ]
    Number of homolateral recurrences of Bartholin's abscess, declared by the patient

  4. Comparison of Word catheter versus incision-drainage concerning pain [ Time Frame: 12 months ]
    Pain numeric scale from 0 to 10

  5. Comparison of Word catheter versus incision-drainage concerning management time [ Time Frame: Day 0 (procedure day), Day 1 ]
    Date and time of patient initial management (randomization) Date and time of the beginning of the procedure date and time of the end of the procedure date and time of the hospital departure

  6. Comparison of Word catheter versus incision-drainage in terms of complications [ Time Frame: 12 months ]
    number of complications related to the procedure (healing complications, infection, lost of the Word catheter), contro-lateral Bartholin's abscess occurrence

  7. Comparison of Word catheter versus incision-drainage in terms of surgical failure [ Time Frame: Immediate post-operative (D0) and one month ]
    Word catheter: insertion failure, loss, removal decision (from the patient or the surgeon) Incision-drainage: incomplete drainage

  8. Comparison of Word catheter versus incision-drainage in terms of impact on sexual activity [ Time Frame: Baseline, one month, 6 months and 12 months ]
    Score of the Female Sexual Function Index: self-questionnaire including 19 questions assessing different parameters of the sexual activity

  9. Comparison of Word catheter versus incision-drainage in terms of quality of life using the SF-12-HS [ Time Frame: Baseline, one month, 6 months and 12 months ]
    Short-Form-12-Health-Survey questionnaire score: self-questionnaire including 12 questions measuring different aspects of quality of life

  10. Comparison of Word catheter versus incision-drainage in terms of quality of life using the EQ-5D [ Time Frame: Baseline, one day, one month, 3 months, 6 months, 9 months and 12 months ]
    EQ-5D 5L score (described in primary outcome)

  11. Comparison of Word catheter versus incision-drainage in terms global patient impression and improvement [ Time Frame: One day, one month, 3 months, 6 months, 9 months and 12 months ]
    Patient Global Impression and Improvement (PGI-I) global index used to rate the response of a condition to a therapy (transition scale). It is a single question asking the patient to rate their global condition now, as compared with how it was prior to before beginning treatment on a scale from 1 - very much better to 7 - very much worse



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Abscess of Bartholin's gland Patient able to understand the protocol Patient who signed informed consent Patient with social insurance

Exclusion Criteria:

Spontaneous fistulization of the abscess before surgical treatment Abscess volume under 3 ml Medical treatment which avoid incision or word catheter placement patients under guardianship Unable to complete questionnaires Patients not affiliated to social protection regimen Pregnant or post-partum women (until 4 weeks after delivery)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04093310


Contacts
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Contact: Thibault Thubert, PhD +33 2 53 48 24 43 thibault.thubert@chu-nantes.fr
Contact: Cécile DERT +33 2 53 48 28 52 cecile.dert@chu-nantes.fr

Locations
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France
Chu Angers Recruiting
Angers, France
Contact: GUILLAUME LEGENDRE, MD    0241354459    GUILLAUME.LEGENDRE@CHU-ANGERS.FR   
CHU CAEN Not yet recruiting
Caen, France
Contact: ANNE CECILE PIZZOFERRATO, MD    0231063106    ACPIZZOFE@GMAIL.COM   
Ch Antoine Beclere Not yet recruiting
Clamart, France
Contact: Xavier DEFFIEUX, MD    0145374444    XAVIER.DEFFIEUX@APHP.FR   
Chu Estaing Not yet recruiting
Clermont-Ferrand, France
Contact: SANDRINE CAMPAGNE LOISEAU, MD    0473750621    SCAMPAGNE-LOISEAU@CHU-CLERMONTFERRAND.FR   
Institut Franco Britannique Recruiting
Levallois-Perret, France
Contact: CAROLINE TRICHOT, MD    0685541983    TRICHOTCARO@GMAIL.COM   
Chu Lille Recruiting
Lille, France
Contact: GERALDINE GIRAUDET, MD    0320446584    GERALDINE.GIRAUDET@CHRU-LILLE.FR   
Chu Nantes Recruiting
Nantes, France
Contact: thibault THUBERT, md    0647697800    thibault.thubert@chu-nantes.fr   
Chu Caremeau Recruiting
Nîmes, France
Contact: VINCENT LETOUZEY, MD    0662576010    VINCENT.LETOUZEY@CHU-NIMES.FR   
Ch Kremlin Bicetre Not yet recruiting
Paris, France
Contact: Perrine CAPMAS, MD    0145217590    Perrine.capmas@aphp.fr   
Chu Cochin Not yet recruiting
Paris, France
Contact: PAUL MARZOUK, MD    0158413681    PAUL.MARZOUK@APHP.FR   
Chu Robert Debre Not yet recruiting
Paris, France
Contact: THOMAS SCHMITZ, MD    0140032000    THOMAS.SCHMITZ@APHP.FR   
Chi Poissy Not yet recruiting
Poissy, France
Contact: ARNAUD FAUCONNIER, MD    0139274004    AFAUCONNIER@CHI-POISSY-ST-GERMAIN.FR   
Chu Poitiers Recruiting
Poitiers, France
Contact: AMELIE CHARVERIAT, MD    0549444444    A.CHARVERIAT@GMAIL.COM   
Chu Toulouse Recruiting
Toulouse, France
Contact: FABIEN VIDAL, MD    0567771111    DOX_94@YAHOO.FR   
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Thibault Thubert, PhD CHU de Nantes

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT04093310    
Other Study ID Numbers: RC19_0179
First Posted: September 18, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
incision-drainage
Bartholin's abscess
Word catheter
Marsupialization
Cost-utility analysis
Additional relevant MeSH terms:
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Abscess
Surgical Wound
Wounds and Injuries
Suppuration
Infection
Inflammation
Pathologic Processes